Roth Net Polyp Retrieval
FDA Recall Z-1416-2017 · Posted 2017-03-08
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Recalling FirmUS Endoscopy Group Inc
Recall StatusTerminated
Product CodeGCJ
Date Initiated2016-12-13
Date Terminated2017-06-13
Product Quantity2,131 units
Reason for Recall
The firm was notified that the expiration date on the outer carton is different than the expiration date on the inner package. The expiration date is shorter than the actual expiration.
Firm Action
US Endoscopy Group sent an Urgent: Roth Net Polyp Retriever Recall letter dated January 6, 2017, to all affected customers.
The firm requested their customers to do the following:
1. Quarantine and destroy the affected Roth Net devices in your inventory.
2. Contact US Endoscopy Customer Service at 1-800-769-8226 to obtain no cost replacement product.
3. Complete and return the attached Response Card.
For further information please call (440) 358-6055.
Root Cause
Labeling mix-ups
Distribution Pattern
US Distribution to the states of : AL, CA, CO, IL, KS, MA, MT, NC , NE , NY, OH, PA, TN, TX and WA. Product was also shipped to the following countries: Australia, Belgium, Canada, Czech Republic, Ireland, Kuwait, Norway, Poland & Sweden.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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